Ha M-Core B-Li-M 80 Slv
EUDAMEDFDA UDIClass IIa (EU MDR)
by Wsaud A/S
Identity
- Trade Name
- HA M-CORE B-LI-M 80 SLV EUDAMEDRexton FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- M-CORE B-LI-M 80 Silver FDA UDI
- Model / Reference
- BTE EUDAMED10991201 EUDAMEDM-CORE B-LI-M 80 FDA UDI
- Description
- M-CORE B-LI-M 80 Silver FDA UDI
Identifiers
- Catalog Number
- 10991201 FDA UDI
- Primary DI / UDI-DI
- 05714880109993 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-25-10-37 EUDAMED
- FDA Product Code
- ESD FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI874.3400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Air-conduction hearing aid, behind-the-ear
Ha M-Core B-Li-M 80 Slv by Wsaud A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
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- NUEAR — Starkey Laboratories Inc. · Class II
- HHM — Oticon A/S · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5714880-WSA-25-10-37 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED d42f6d3e-8453-473f-88e5-355af0bae6b8 61 fields · synced Jul 23, 2026
- FDA UDI e9a75052-5d31-4224-b4ea-95fcfd8ab349 35 fields · synced May 29, 2026